Whole Blood in Trauma Patients With Hemorrhagic Shock
Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial
Fundacion Clinica Valle del Lili
220 participants
Jan 14, 2023
INTERVENTIONAL
Conditions
Summary
This study aims to evaluate among trauma patients with hemorrhagic shock the clinical impact of hemostatic resuscitation between whole blood vs. blood components therapy in the following outcomes in a hierarchical analysis: mortality at 28 days and evolution of organ dysfunction.
Eligibility
Inclusion Criteria4
- Adult patients (\> 18 years)
- Activating institutional trauma code for trauma patients with hemorrhagic shock.
- Candidate for massive transfusion (Patient with an Assessment Blood Consumption (ABC) Score ≥ 2 or at the discretion of the treating physician)
- Concurrent availability of whole blood or blood component therapy
Exclusion Criteria15
- More than 4 hours from trauma to hospital admission
- More than 2 hours from hospital admission to randomization
- Transfusion of more than one packed red blood cell unit prior to randomization.
- Patients who have undergone surgery (laparotomy, thoracotomy, or sternotomy) before hospital admission.
- In-extremis patients with devastating injuries (expected to die within 60 minutes).
- Blood group other than to O or A and positive Rh factor
- Severe traumatic brain injury in which neurosurgical intervention is futile (partial decapitation, massive intracranial hemorrhage, or transcranial gunshot wounds).
- Burns over 20% of the total body surface area.
- Suspected airway burn.
- Cardiopulmonary resuscitation (CPR) before arrival at the ED.
- CPR for more than 5 minutes before randomization.
- Do not resuscitate order.
- Incarcerated/prisoners.
- Known pregnancy in the ED.
- Patient or legal representative who refuse to participate in clinical research studies.
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Interventions
The intervention will be either a) administration of 6 units of whole blood or b) administration of blood component therapy in the proportion of 6:6:6 units of red blood cells, plasma, and platelets.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05634109